<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>00841517101015</udiDi>
    <basicUdiDi>B-00841517101015</basicUdiDi>
    <tradeName>HFL38xp/13-6 MHz</tradeName>
    <deviceName>TRANSDUCER, HFL38XP/13-6 MHZ</deviceName>
    <manufacturerName>Fujifilm Sonosite, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000001075</manufacturerSrn>
    <authorisedRepresentativeName>Fujifilm Sonosite B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000046</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z110402010101</emdnCode>
    <emdnDescription>TWO–DIMENSIONAL LINEAR–ARRAY TRANSCUTANEOUS ULTRASOUND PROBES</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>P16038-20</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-05T04:28:47.697Z</lastUpdated>
  </row>
  <row>
    <udiDi>00841517101008</udiDi>
    <basicUdiDi>B-00841517101008</basicUdiDi>
    <tradeName>HFL50xp/15-6 MHz</tradeName>
    <deviceName>TRANSDUCER, HFL50XP/15-6 MHZ</deviceName>
    <manufacturerName>Fujifilm Sonosite, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000001075</manufacturerSrn>
    <authorisedRepresentativeName>Fujifilm Sonosite B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000046</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z110402010101</emdnCode>
    <emdnDescription>TWO–DIMENSIONAL LINEAR–ARRAY TRANSCUTANEOUS ULTRASOUND PROBES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P14567-22A</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-05T04:28:46.899Z</lastUpdated>
  </row>
  <row>
    <udiDi>00841517100995</udiDi>
    <basicUdiDi>B-00841517100995</basicUdiDi>
    <tradeName>HFL50xp/15-6 MHz</tradeName>
    <deviceName>TRANSDUCER, HFL50XP/15-6 MHZ</deviceName>
    <manufacturerName>Fujifilm Sonosite, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000001075</manufacturerSrn>
    <authorisedRepresentativeName>Fujifilm Sonosite B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000046</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z110402010201</emdnCode>
    <emdnDescription>CURVILINEAR TRANSCUTANEOUS TWO–DIMENSIONAL ULTRASOUND PROBES  (CONVEX–ARRAY)</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>P14567-22</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-05T04:28:46.112Z</lastUpdated>
  </row>
  <row>
    <udiDi>00841517100988</udiDi>
    <basicUdiDi>B-00841517100988</basicUdiDi>
    <tradeName>C11xp/8-5 MHz</tradeName>
    <deviceName>TRANSDUCER, C11XP/8-5 MHZ</deviceName>
    <manufacturerName>Fujifilm Sonosite, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000001075</manufacturerSrn>
    <authorisedRepresentativeName>Fujifilm Sonosite B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000046</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z110402010201</emdnCode>
    <emdnDescription>CURVILINEAR TRANSCUTANEOUS TWO–DIMENSIONAL ULTRASOUND PROBES  (CONVEX–ARRAY)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P14564-20A</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-05T04:28:45.322Z</lastUpdated>
  </row>
  <row>
    <udiDi>00841517100971</udiDi>
    <basicUdiDi>B-00841517100971</basicUdiDi>
    <tradeName>C11xp/8-5 MHz</tradeName>
    <deviceName>TRANSDUCER, C11XP/8-5 MHZ</deviceName>
    <manufacturerName>Fujifilm Sonosite, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000001075</manufacturerSrn>
    <authorisedRepresentativeName>Fujifilm Sonosite B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000046</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z110402010201</emdnCode>
    <emdnDescription>CURVILINEAR TRANSCUTANEOUS TWO–DIMENSIONAL ULTRASOUND PROBES  (CONVEX–ARRAY)</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>P14564-20</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-05T04:28:41.393Z</lastUpdated>
  </row>
  <row>
    <udiDi>00841517100964</udiDi>
    <basicUdiDi>B-00841517100964</basicUdiDi>
    <tradeName>C60xp/5-2 MHz</tradeName>
    <deviceName>TRANSDUCER, C60XP/5-2 MHZ</deviceName>
    <manufacturerName>Fujifilm Sonosite, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000001075</manufacturerSrn>
    <authorisedRepresentativeName>Fujifilm Sonosite B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000046</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z110402010201</emdnCode>
    <emdnDescription>CURVILINEAR TRANSCUTANEOUS TWO–DIMENSIONAL ULTRASOUND PROBES  (CONVEX–ARRAY)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P14561-20A</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-05T04:28:39.689Z</lastUpdated>
  </row>
  <row>
    <udiDi>00841517100957</udiDi>
    <basicUdiDi>B-00841517100957</basicUdiDi>
    <tradeName>C60xp/5-2 MHz</tradeName>
    <deviceName>TRANSDUCER, C60XP/5-2 MHZ</deviceName>
    <manufacturerName>Fujifilm Sonosite, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000001075</manufacturerSrn>
    <authorisedRepresentativeName>Fujifilm Sonosite B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000046</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z110402010201</emdnCode>
    <emdnDescription>CURVILINEAR TRANSCUTANEOUS TWO–DIMENSIONAL ULTRASOUND PROBES  (CONVEX–ARRAY)</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>P14561-20</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-05T04:28:38.889Z</lastUpdated>
  </row>
  <row>
    <udiDi>00841517100940</udiDi>
    <basicUdiDi>B-00841517100940</basicUdiDi>
    <tradeName>FC1 Ultrasound System</tradeName>
    <deviceName>FC1 ULTRASOUND SYSTEM</deviceName>
    <manufacturerName>Fujifilm Sonosite, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000001075</manufacturerSrn>
    <authorisedRepresentativeName>Fujifilm Sonosite B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000046</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z11040103</emdnCode>
    <emdnDescription>PORTABLE ULTRASOUND SCANNERS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>P16951-22</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-05T04:28:38.088Z</lastUpdated>
  </row>
  <row>
    <udiDi>00841517100933</udiDi>
    <basicUdiDi>B-00841517100933</basicUdiDi>
    <tradeName>SonoSite X-Porte</tradeName>
    <deviceName>X-PORTE ULTRASOUND SYSTEM</deviceName>
    <manufacturerName>Fujifilm Sonosite, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000001075</manufacturerSrn>
    <authorisedRepresentativeName>Fujifilm Sonosite B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000046</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z11040103</emdnCode>
    <emdnDescription>PORTABLE ULTRASOUND SCANNERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P19220-60</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-05T04:28:34.088Z</lastUpdated>
  </row>
  <row>
    <udiDi>00841517100926</udiDi>
    <basicUdiDi>B-00841517100926</basicUdiDi>
    <tradeName>SonoSite X-Porte</tradeName>
    <deviceName>X-PORTE ULTRASOUND ENGINE</deviceName>
    <manufacturerName>Fujifilm Sonosite, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000001075</manufacturerSrn>
    <authorisedRepresentativeName>Fujifilm Sonosite B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000046</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z11040103</emdnCode>
    <emdnDescription>PORTABLE ULTRASOUND SCANNERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P17880-55</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-05T04:28:33.294Z</lastUpdated>
  </row>
  <row>
    <udiDi>00841517100919</udiDi>
    <basicUdiDi>B-00841517100919</basicUdiDi>
    <tradeName>SonoSite NanoMaxx</tradeName>
    <deviceName>NANOMAXX ULTRASOUND SYSTEM</deviceName>
    <manufacturerName>Fujifilm Sonosite, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000001075</manufacturerSrn>
    <authorisedRepresentativeName>Fujifilm Sonosite B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000046</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z11040103</emdnCode>
    <emdnDescription>PORTABLE ULTRASOUND SCANNERS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>P11111-60R</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-05T04:28:32.487Z</lastUpdated>
  </row>
  <row>
    <udiDi>00841517100902</udiDi>
    <basicUdiDi>B-00841517100902</basicUdiDi>
    <tradeName>SonoSite NanoMaxx</tradeName>
    <deviceName>NANOMAXX ULTRASOUND SYSTEM</deviceName>
    <manufacturerName>Fujifilm Sonosite, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000001075</manufacturerSrn>
    <authorisedRepresentativeName>Fujifilm Sonosite B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000046</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z11040103</emdnCode>
    <emdnDescription>PORTABLE ULTRASOUND SCANNERS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>P11111-60</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-05T04:28:31.688Z</lastUpdated>
  </row>
  <row>
    <udiDi>00841517100896</udiDi>
    <basicUdiDi>B-00841517100896</basicUdiDi>
    <tradeName>SonoSite iViz</tradeName>
    <deviceName>IVIZ MEDICAL DIAGNOSTIC TABLET</deviceName>
    <manufacturerName>Fujifilm Sonosite, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000001075</manufacturerSrn>
    <authorisedRepresentativeName>Fujifilm Sonosite B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000046</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z11040103</emdnCode>
    <emdnDescription>PORTABLE ULTRASOUND SCANNERS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>P20830-14</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-05T04:28:27.684Z</lastUpdated>
  </row>
  <row>
    <udiDi>00841517100889</udiDi>
    <basicUdiDi>B-00841517100889</basicUdiDi>
    <tradeName>L38v/10-5 MHz</tradeName>
    <deviceName>TRANSDUCER, L38V 10-5 MHZ, IVIZ</deviceName>
    <manufacturerName>Fujifilm Sonosite, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000001075</manufacturerSrn>
    <authorisedRepresentativeName>Fujifilm Sonosite B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000046</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z110402010101</emdnCode>
    <emdnDescription>TWO–DIMENSIONAL LINEAR–ARRAY TRANSCUTANEOUS ULTRASOUND PROBES</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>P19360-17</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-05T04:28:26.983Z</lastUpdated>
  </row>
  <row>
    <udiDi>00841517100872</udiDi>
    <basicUdiDi>B-00841517100872</basicUdiDi>
    <tradeName>P21n/5-1 MHz</tradeName>
    <deviceName>TRANSDUCER, P21V 5-1 MHZ, IVIZ</deviceName>
    <manufacturerName>Fujifilm Sonosite, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000001075</manufacturerSrn>
    <authorisedRepresentativeName>Fujifilm Sonosite B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000046</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z110402010301</emdnCode>
    <emdnDescription>TRANSCUTANEOUS ULTRASOUND SECTOR PROBES (PHASED ARRAY), TWO–DIMENSIONAL</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>P18800-15</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-05T04:28:25.295Z</lastUpdated>
  </row>
  <row>
    <udiDi>00841517100865</udiDi>
    <basicUdiDi>B-00841517100865</basicUdiDi>
    <tradeName>P21n/5-1 MHz</tradeName>
    <deviceName>TRANSDUCER, P21N/5-1 MHZ, NANOMAXX</deviceName>
    <manufacturerName>Fujifilm Sonosite, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000001075</manufacturerSrn>
    <authorisedRepresentativeName>Fujifilm Sonosite B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000046</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z110402010301</emdnCode>
    <emdnDescription>TRANSCUTANEOUS ULTRASOUND SECTOR PROBES (PHASED ARRAY), TWO–DIMENSIONAL</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>P11879-70A</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-05T04:28:24.489Z</lastUpdated>
  </row>
  <row>
    <udiDi>00841517100858</udiDi>
    <basicUdiDi>B-00841517100858</basicUdiDi>
    <tradeName>P21n/5-1 MHz</tradeName>
    <deviceName>TRANSDUCER, P21N/5-1 MHZ, NANOMAXX</deviceName>
    <manufacturerName>Fujifilm Sonosite, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000001075</manufacturerSrn>
    <authorisedRepresentativeName>Fujifilm Sonosite B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000046</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z110402010301</emdnCode>
    <emdnDescription>TRANSCUTANEOUS ULTRASOUND SECTOR PROBES (PHASED ARRAY), TWO–DIMENSIONAL</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>P11879-70</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-05T04:28:20.489Z</lastUpdated>
  </row>
  <row>
    <udiDi>00841517100841</udiDi>
    <basicUdiDi>B-00841517100841</basicUdiDi>
    <tradeName>L38n/10-5 MHz</tradeName>
    <deviceName>TRANSDUCER, L38N/10-5 MHZ, NANOMAXX</deviceName>
    <manufacturerName>Fujifilm Sonosite, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000001075</manufacturerSrn>
    <authorisedRepresentativeName>Fujifilm Sonosite B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000046</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z110402010101</emdnCode>
    <emdnDescription>TWO–DIMENSIONAL LINEAR–ARRAY TRANSCUTANEOUS ULTRASOUND PROBES</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>P11877-70A</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-05T04:28:19.696Z</lastUpdated>
  </row>
  <row>
    <udiDi>00841517100834</udiDi>
    <basicUdiDi>B-00841517100834</basicUdiDi>
    <tradeName>L38n/10-5 MHz</tradeName>
    <deviceName>TRANSDUCER, L38N/10-5 MHZ, NANOMAXX</deviceName>
    <manufacturerName>Fujifilm Sonosite, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000001075</manufacturerSrn>
    <authorisedRepresentativeName>Fujifilm Sonosite B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000046</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z110402010101</emdnCode>
    <emdnDescription>TWO–DIMENSIONAL LINEAR–ARRAY TRANSCUTANEOUS ULTRASOUND PROBES</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>P11877-70</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-05T04:28:18.893Z</lastUpdated>
  </row>
  <row>
    <udiDi>00841517100827</udiDi>
    <basicUdiDi>B-00841517100827</basicUdiDi>
    <tradeName>L25n/13-6 MHz</tradeName>
    <deviceName>TRANSDUCER, L25N-128/13-6 MHZ, NANOMAXX</deviceName>
    <manufacturerName>Fujifilm Sonosite, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000001075</manufacturerSrn>
    <authorisedRepresentativeName>Fujifilm Sonosite B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000046</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z110402010101</emdnCode>
    <emdnDescription>TWO–DIMENSIONAL LINEAR–ARRAY TRANSCUTANEOUS ULTRASOUND PROBES</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>P12092-70A</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-05T04:28:18.097Z</lastUpdated>
  </row>
</eudamedExport>